DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 7/1/2026 has been received and entered into the case.
Claims 12-16 and 19-20 have been canceled, claims 21-24 are newly added, and claims 1-11, 17-18 and 21-24 have been considered on the merits. All arguments have been considered.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 18/080373, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The ‘373 application fails to provide adequate support for the limitations disclosed in claims 10-11, 17-18 and 21-24. As discussed below under the objection to the specification, the limitations of claims 10-11, 17-18 and 21-24 disclose “feed medium” comprising the claimed ingredients, i.e. nicotinamide and 5-methylthioadenosine at the claimed concentration range. There is no disclosure in the originally filed specification to provide support for the claimed limitations. It is noted that the concentration range disclosed for nicotinamide and 5-methylthioadenosine in the specification of the ‘373 is directed to the cell culture medium but not to the “feed medium”. It is understood that “cell culture medium” is different from “feed medium” as claimed. Regarding claims 21-22 directed to the feed medium that has less than 50 nM of nicotinamide and less than 10 nM of 5-methylthioadenosine, this limitation is not supported by the disclosure of the ‘373 application. The specification of the ‘373 application discloses that the nicotinamide and/or the 5-methylthioadenosine concentration in the cell culture medium, not the feed medium.
Thus, the priority claim to the ‘373 application is not granted, and the earliest filing date for claims 10-11, 17-18 and 21-24 of the instant application is 11/20/2023. The priority date for claims 1-9 is granted to the filing date of 62/837,263, which is 4/23/2019.
The claim rejection under 35 USC 35 U.S.C. 103 based on Xue et al. has been modified to address the instant amendment and the new claims.
The claim rejection under 35 USC 35 U.S.C. 103 based on Johnson et al. in view of Gorfien et al. has been withdrawn to simplify the prosecution as the pending claims are rejected under Xue et al. It is also noted that the 103 rejection to claim 12 has been withdrawn due to the instant amendment.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claims 10-11 and 21-24 disclose that the feed media comprises 50-2000 nM nicotinamide and 10-200 nM 5-methylthioadenosine. The instant specification fails to provide antecedent basis for the claimed limitation as there is no disclosure for the feed medium comprising the claimed ingredient at the concentration.
Claim Rejections - 35 USC § 112 (New Rejection)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10-11, 17-18 and 21-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 10 discloses a new limitation that the feed medium comprises between 50-2000 nM of nicotinamide. While the instant specification discloses various concentration of nicotinamide in the cell culture medium, however, the specification does not provide sufficient written description for the claimed concentration as there is no disclosure of the concentration of nicotinamide in the feed medium.
Claims 21-22 disclose the titer of the aflibercept produced by the method of claim 10 or 11 being at least 2% greater compared to using the feed medium that has less than 50 nM of nicotinamide (claim 21) or the feed medium that has less than 50 nM of nicotinamide and less than 10 nM of 5-methythioadenosine (claim 22).
The instant specification fails to provide support for the claimed limitation. The instant specification discloses: “In one aspect of this embodiment, a titer of a protein grown in the cell culture medium is at least about 2% greater than another cell culture medium not comprising at least about 10 nM 5-methylthioadenosine. In another aspect of this embodiment, a titer of a protein grown in the cell culture medium is at least about 2% greater than another cell culture medium not comprising at least about 50 nM nicotinamide.” The results of “at least about 2% greater” titer of a protein (including aflibercept) when the aflibercept is produced by culturing eukaryotic cells expressing aflibercept in a cell culture medium comprising at least about 50 nM of nicotinamide and at least 10 nM of 5-methylthioadenosine.
However, the instant claims disclose that the cell culture medium is supplemented with a feed medium, and the feed medium comprises between 50-2000 nM of nicotinamide and/or 10-200 nM of 5-methylthioadenosine. As there is no particular amount of the feed medium being supplemented to the cell culture medium, and there is no disclosure of the concentration of nicotinamide and/or 5-methylthioadenosine in the cell culture medium prior to the supplementation, the final concentration of nicotinamide and/or 5-methylthioadenosine is not known and thus, the scope would be much broader than the cell culture medium comprising the final concentration of nicotinamide and/or 5-methylthioadenosin required for producing at least 2% greater titer of aflibercept compared to the feed medium that has less than 50 nm of nicotinamide or less than 10 nM of 5-methylthioadenosine.
Thus, claims 10-11, 17-18 and 21-24 are considered to introduce new matter to the instant application.
In amended cases, subject matter not disclosed in the original application is sometimes added and a claim directed thereto. Such a claim is rejected on the ground that it recites elements without support in the original disclosure under 35 U.S.C. 112, first paragraph, Waldemar Link, GmbH & Co. v. Osteonics Corp. 32 F.3d 556, 559, 31 USPQ2d 1855, 1857 (Fed. Cir. 1994); In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981). See MPEP § 2163.06 - § 2163.07(b) for a discussion of the relationship of new matter to 35 U.S.C. 112, first paragraph. New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 to § 608.04(c). See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and MPEP § 2163.05 for guidance in determining whether the addition of specific percentages or compounds after a broader original disclosure constitutes new matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10-11, 17-18 and 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xue et al. (US PAT. 10,961,500)
As discussed above under Specification, the priority date of claims 10-11 and 17-18 has been determined as 11/20/2023, and thus, the cited reference is qualified as a prior art.
Regarding claims 10-11, Xue et al. teach a method of producing aflibercept by culturing eukaryotic cells expressing aflibercept in a cell culture medium comprising 10-200 nM of 5-methylthioadenosine and 50-2000 nM of nicotinamide (col. 2). Xue et al. teach that the cell culture medium can comprise a feed medium (col. 2). However, Xue et al. do not teach that the feed medium comprising the 5-methylthioadenosine and nicotinamide as required. However, it would have been obvious to a person skilled in the art to use 5-methylthioadenosine and nicotinamide in the feed medium with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because Xue et al. teach that the feed medium includes a medium containing one or more nutrients that can be added to the culture beginning [and/or] at some time after inoculation (col. 11). As 5-methylthioadenosine is supplemented to the cell culture medium (col. 20, claim 1), one skilled in the art would use the feed medium to supplement 5-methylthioadenosine to the cell culture medium. For the same reason, one skilled in the art would supplement nicotinamide as a part of the feed medium to the cell culture medium.
Regarding claims 17-18 directed to soy hydrolysate, Xue et al. teach that the feed medium comprises a basal medium and at least one type of hydrolysate, e.g. soy-based hydrolysate (col.11).
Regarding claims 21-22, the wherein clause of the claims is directed to the result of the claimed method but does not require any active step to be carried out for the claimed method. As Xue et al. would arrive to the claimed method of claims 10 and 11 as discussed above, the results of the method taught by Xue et al. would be expected the same. Particularly, Xue et al. teach that the cell culture medium comprising at least about 50 nM nicotinamide can produce a titer of a protein at least about 2% greater than another cell culture medium that does not have at least about 50 nM nicotinamide or the cell culture medium comprising at least about 10 nM 5-methylthioadenosine can produce a titer of a protein at least about 2% greater than another cell culture medium that does not have at least about 10 nM 5-methylthioadenosine (col. 16, lines 26-30; col. 15, lines 60-65). Thus, the cell culture medium of Xue et al. regardless of additional feed medium supplementation can produce the claimed effect when the concentration of nicotinamide and/or 5-methylthioadenosine as claimed is met. Thus, one skilled in the art would recognize that the supplementation of a feed medium with the claimed concentration would result in the same outcome as claimed.
Regarding claims 23-24 directed to the feed medium comprising a basal medium, Xue et al. teach that the feed medium includes a basal medium (col. 11, lines 40-49).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11, 17-18 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,961,500 in view of Johnson et al. (supra), Maiorella et al. (supra) and Li et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘500 patent disclose a method of culturing eukaryotic cells to produce aflibercept comprising culturing the eukaryotic cells in a culture medium supplemented with 5-methylthioadenosine at 10-200 nM. The claims of the ‘500 patent disclose other cell culture medium components as claimed in the instant application (RE: claim 3), serum-free medium (RE: claim 6), or a chemically-defined medium (RE: claim 7).
Regarding the nicotinamide at 50-1500 nM in the feed medium (RE: claim 10), the claims of the ‘500 patent do not disclose the limitation. However, it is known in the art that nicotinamide is used in the cell culture medium for producing a recombinant protein such as aflibercept according to Johnson et al., and Johnson et al. teach the cell culture medium comprising the claimed concentration of nicotinamide. As Johnson et al. teach the use of feed medium, it would have been obvious to a person skilled in the art to use the feed medium comprising the nicotinamide to be supplemented into the cell culture medium for producing aflibercept.
Regarding claims 17-18 directed to soy hydrolysate, Johnson et al. teach that the serum-free medium contain soy hydrolysate (para. 59). Thus, it would have been obvious to use soy hydrolysate in the method of the ‘500 patent.
Regarding claims 21-22, the claims of the ‘500 patent disclose that the presence of at least about 10 nM of 5-methylthioadenosine produce aflibercept at least about 2% greater than the cell culture medium that does not have at least about 10 nM 5-methylthioadenosine. Regarding the nicotinamide, as both 5-methylthioadenosine and nicotinamide are utilized in the method disclosed by the ‘500 patent in view of Johnson et al., it is expected that at least 2% greater production of aflibercept is expected.
Regarding claims 23-24, the claims of the ‘500 patent do not particularly teach the limitation. However, it is extremely well known in the art that a basal medium is utilized for different type of cell culture medium including a cell culture medium, a feed medium, etc.
Thus, the claims of the ‘500 patent in view of the cited references render the claims of the instant application obvious.
Claims 1-11, 17-18 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,286,460 in view of Johnson et al. (supra), Maiorella et al. (supra) and Li et al. (supra) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘460 patent teach a method for culturing eukaryotic cells to produce a recombinant protein by culturing eukaryotic cells in a defined cell culture medium supplemented with nicotinamide at a concentration of 50-1500 nM and/or 5-methylthioadenosine at about 10-200 nM. The claims of the ‘460 patent also disclose that the cell culture medium is serum-free or chemically-defined.
The claims of the ‘460 patent do not particularly teach the recombinant protein being aflibercept, however, it is known in the art that a protein of interest can be expressed in eukaryotic cells in a cell culture medium and aflibercept is one example that can be produced by such method according to Johnson et al. Thus, it would have been obvious to a person skilled in the art to use the method of the ‘460 patent for producing aflibercept with a reasonable expectation of success. Furthermore, the scope of the recombinant protein of the ‘460 patent encompasses aflibercept according to the specification of the ‘460 patent.
Regarding the nicotinamide at 50-1500 nM or 50-800 nM in the feed medium (RE: claim 10), the claims of the ‘460 patent do not disclose the limitation. However, it is known in the art that cell culture supplement ingredients would be supplemented to the cell culture medium in the form of a concentrated feed medium according to Johnson et al. (para. 91). As Johnson et al. teach the use of feed medium, it would have been obvious to a person skilled in the art to use the feed medium comprising the nicotinamide as well as 5-methylthioadenosine of the ‘460 patent to be supplemented into the cell culture medium for producing aflibercept.
Regarding claims 17-18 directed to soy hydrolysate, Johnson et al. teach that the serum-free medium contain soy hydrolysate (para. 59). Thus, it would have been obvious to use soy hydrolysate in the method of the ‘460 patent.
Regarding claims 21-22, the claims of the ‘460 patent disclose that the presence of at least about 10 nM of 5-methylthioadenosine produce aflibercept at least about 2% greater than the cell culture medium that does not have at least about 10 nM 5-methylthioadenosine. Regarding the nicotinamide, as both 5-methylthioadenosine and nicotinamide are utilized in the method disclosed by the ‘460 patent in view of Johnson et al., it is expected that at least 2% greater production of aflibercept is expected.
Regarding claims 23-24, the claims of the ‘460 patent do not particularly teach the limitation. However, it is extremely well known in the art that a basal medium is utilized for different type of cell culture medium including a cell culture medium, a feed medium, etc.
Thus, the claims of the ‘460 patent in view of the cited references render the claims of the instant application obvious.
Claims 1-11, 17-18 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,555,176 in view of Johnson et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘176 patent disclose a method for culturing eukaryotic cells to produce aflibercept by culturing the eukaryotic cells expressing aflibercept in a cell culture medium supplemented with 5-methylthioadenosine at 10-200 nM and nicotinamide at 100-800 nM. The claims of the ‘176 patent further disclose the cell culture ingredients disclosed in the instant claims (RE: claims 3-4); pH 6.5-8.0 (RE: claim 5); serum-free or chemically defined medium (RE: claims 6-7).
Regarding the feed medium comprising nicotinamide at 50-1500 nM or 50-800 nM (RE: claim 10) or 5-methylthioadenosine at 10-200 nM or 10-130 nM (RE: claim 11), the claims of the ‘176 patent do not disclose “feed medium”. However, as the claims of the ‘176 patent disclose a step of supplementing the cell culture medium with nicotinamide and/or 5-methylthioadenosine, and Johnson et al. teach the use of a concentrated feed medium to supplement a cell culture medium for the method of producing a recombinant protein such as aflibercept, it would have been obvious to a person skilled in the art to use a feed medium comprising supplemental ingredients to add to the cell culture medium with a reasonable expectation of success.
Regarding the use of soy hydrolysate in the cell culture medium (RE: claims 17-18), the claims of the ‘176 patent do not disclose the limitation. However, it is known in the art that soy hydrolysate can be used in a serum-free medium for producing a recombinant protein such as aflibercept according to Johnson et al. (para. 59). Thus, it would have been obvious to a person skilled in the art to use soy hydrolysate for the method of the ‘176 patent with a reasonable expectation of success.
Regarding claims 21-22, the claims of the ‘176 patent disclose that the presence of at least about 10 nM of 5-methylthioadenosine produce aflibercept at least about 2% greater than the cell culture medium that does not have at least about 10 nM 5-methylthioadenosine. Regarding the nicotinamide, as both 5-methylthioadenosine and nicotinamide are utilized in the method disclosed by the ‘176 patent in view of Johnson et al., it is expected that at least 2% greater production of aflibercept is expected.
Regarding claims 23-24, the claims of the ‘176 patent do not particularly teach the limitation. However, it is extremely well known in the art that a basal medium is utilized for different type of cell culture medium including a cell culture medium, a feed medium, etc.
Thus, the claims of the ‘176 patent in view of Johnson et al. render the claims of the instant application obvious.
Claims 1-11, 17-18 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,821,001 in view of Johnson et al. (supra) and Daly et al. (US Pat. 7,279,159; IDS ref.). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘001 patent disclose a method for culturing eukaryotic cells to produce a fusion protein capable of binding to VEGF by culturing the eukaryotic cells expressing the fusion protein in a cell culture medium supplemented with 5-methylthioadenosine at 10-200 nM and nicotinamide at 50-1500 nM. While the fusion protein capable of binding to VEGF is not particularly defined as aflibercept, however, the scope of the “fusion protein capable of binding to VEGF” would encompass aflibercept according to the specification of the ‘001 patent referring to Daly et al. (i.e. VEGF traps capable of binding to VEGF). The claims of the ‘001 patent also disclose the cell culture medium is serum-free or chemically defined.
Regarding the feed medium comprising nicotinamide at 50-1500 nM or 50-800 nM (RE: claim 10) or 5-methylthioadenosine at 10-200 nM or 10-130 nM (RE: claim 11), the claims of the ‘001 patent do not disclose “feed medium”. However, as the claims of the ‘001 patent disclose a step of supplementing the cell culture medium with nicotinamide and/or 5-methylthioadenosine, and Johnson et al. teach the use of a concentrated feed medium to supplement a cell culture medium for the method of producing a recombinant protein such as aflibercept, i.e. a fusion protein capable of binding to VEGF, it would have been obvious to a person skilled in the art to use a feed medium comprising supplemental ingredients to add to the cell culture medium with a reasonable expectation of success.
Regarding the use of soy hydrolysate in the cell culture medium (RE: claims 17-18), the claims of the ‘001 patent teach plant hydrolysate. Furthermore, Johnson et al. teach the use of soy hydrolysate (para. 59). Thus, it would have been obvious to a person skilled in the art to use soy hydrolysate for the method of the ‘001 patent.
Regarding claims 21-22, the claims of the ‘001 patent disclose that the presence of 10-1500 nM of nicotinamide produce Fc-fusion protein, e.g. aflibercept, at least 2% greater than the cell culture medium that have less than 50 nM 5-nicotinamide. Regarding 5-methylthioadenosine, as both 5-methylthioadenosine and nicotinamide are utilized in the method disclosed by the ‘001 patent in view of Johnson et al., it is expected that at least 2% greater production of aflibercept is also expected using both nicotinamide and 5-methylthioadenosine.
Regarding claims 23-24, the claims of the ‘001 patent do not particularly teach the limitation. However, it is extremely well known in the art that a basal medium is utilized for different type of cell culture medium including a cell culture medium, a feed medium, etc.
Thus, the claims of the ‘001 patent in view of the cited references render the claims of the instant application obvious.
Response to Arguments
Applicant's arguments filed 7/1/2026 have been fully considered but they are not persuasive.
With regard to the priority, applicant alleged that the paragraph 55 discloses a “fed batch” method in which cell culture is fed with a feed medium, and paragraph 67-70 further describe the protein titer and the presence of soy hydrolysate or a basal medium. Applicant further states that paragraph 9 discloses that the medium can be a feed medium with the claimed concentration range. The examiner disagrees with this assertion. As discussed in detail above, it is the examiner’s position that the specification of the instant application as well as the parent applications do not disclose that the feed medium contains the claimed concentration of nicotinamide and/or 5-methylthioadenosine. The disclosure in the specification with regard to the concentration referred by applicant is directed to the concentration of nicotinamide or 5-methylthioadenosine in the cell culture medium, i.e. final concentration, but there is no disclosure of the concentration of nicotinamide or 5-methylthioadenosine for the feed medium. As claimed, the cell culture medium and the feed medium are considered different, and the amount of nicotinamide and/or 5-methylthioadenosine in the final cell culture medium would affect the protein production or titer but not the concentration thereof in the feed medium, particularly when the dilution factor or the amount of the feed medium added to the cell culture medium is not known.
Based on this analysis, Xue et al. is considered 102(a)(1) art.
Regarding the double patent rejections, it is noted that the rejections have been modified in order to address the instant amendment and the new claims. Applicant did not provide any argument, rather indicated that filing terminal disclaimers will be considered. Thus, the double patenting rejections are maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631
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